PREPARE:Assessing the Safety and Efficacy of Radial Versus Femoral Approach PCI (PREPARE)
A Prospective, Multicenter, Randomized Trial Assessing the Safety and Efficacy of PCI Via Radial Versus Femoral Approach in Patients With Left Main and/or Three-Vessel Disease
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Phase
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient must be at least 18 years of age.
- Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides written informed consent prior to the randomization, as approved by the appropriate IEC.
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia).
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Patient with complex lesion who may need two or more than 2 stents implantation during the indexed procedure is required surgeon's consultation before the operation. The surgical consultation outcome must be recorded in detail.
- Patient must agree to undergo all protocol-required follow-up examinations.
- Patient must agree not to participate in any other clinical study within the duration of this trial.
Angiographic inclusion criteria:
- Target lesion must be able to be treated by using six-French guiding catheters.
- Target lesion can be Left Main and/or Multivessel Diseases with Syntax score ≤32 for LM and Syntax score ≤22 for MVD.
Exclusion Criteria:
- Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
- Patient is receiving or scheduled to receive chemotherapy for malignancy.
- Patient is receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease (e.g. Human Immunodeficiency Virus, Lupus etc. Not include diabetes mellitus).
- Known hypersensitivity or contraindication to aspirin, zotarolimus, polymer, Nickel, cobalt, chromium, iron, tungsten, etc. or stainless steel.
- Patient has extensive peripheral vascular disease that precludes safely insertion of 6 French sheath.
- Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
- Female patients of childbearing potential who have refused a urine or blood pregnancy test (to be done within 7 days prior to index procedure), patients who are nursing at the time of index procedure and those patients who do not agree at the time of consent to use any approved form of birth control up to and including the follow-up at 1 year.
- STEMI within 72h prior to procedure.
- History of CABG.
- Radial artery or femoral artery presence serious vascular bend or deformity that the 6F sheath can not go though.
- Based on investigator's clinical judgments, high-risk patients, referring to predicted procedural risks being higher than the procedural benefits must be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Femoral approach group
PCI through Femoral approach
|
|
|
Experimental: radial approach group
PCI through radial approach
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
major adverse cardiac and cerebrovascular events (MACCE) at 12 months
Time Frame: 1 year
|
The primary endpoint is the major adverse cardiac and cerebrovascular events (MACCE) defined as the composite of all-caused death, all stroke, all myocardial infarction (MI), or any revascularization at 12 months.
|
1 year
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The second endpoint is the rate of first occurrence of bleeding complication (BARC Definition type 3 and 5) at 7 days post-procedure
Time Frame: 7 days
|
- The second endpoint is the rate of first occurrence of bleeding complication (BARC Definition type 3 and 5) at 7 days post-procedure
|
7 days
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Other outcomes
Time Frame: 5years
|
|
5years
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Yuejing Yang, Professor, Fuwai Hospital
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- PREPARE
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